Evaluating New Drugs and Medication Related Documents

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DTC Formulary Submission and IPU Application Templates

NSW TAG has developed templates and accompanying tools to assist hospital Drug and Therapeutics Committees in systematic, evidence-based review and decision-making about applications for new medicines or new indications in accordance with NSW Health Policy Directive PD2016_033: Approval Process of Medicines for Use in NSW Public Hospitals

The formulary submission and IPU application template were updated in December 2009 based on feedback from the NSW TAG membership and clinicians working in NSW public hospitals. The updates included prompts for the inclusion of PBAC public summary documents, where relevant, and the acknowledgement of the multidiscplinary nature of these forms.

Templates and Tools

  • Formulary Submissions:

    • Formulary submission templates
      • Formulary submission form: ALL request types V2.1 17Aug21 [PDF] [WORD]
      • Formulary submission form: New or Other request types V1 17Aug21 [PDF] [WORD]
        • Formulary Amendment Form V1 17Aug21 [PDF] [WORD]
        • Formulary S100 Addition Form V1 17Aug21 [PDF] [WORD]
    • Prescribing protocol template (November 2009) [PDF] [Word]
    • DTC decision algorithm for evaluation of medicines [PDF]
  • Device containing Medicines Submissions:

    • Device application template (October 2016) [PDF] [Word]
  • IPU Applications

    • IPU application form V2.1 17 Aug 2021 [PDF] [Word]
    • Decision Algorithm for evaluation of medicines for IPU approval [PDF]

     

  • For all submissions/applications to DTC:

    • Supplementary information template (for use by DTC delegate) V2.1 17 Aug 2021 [PDF] [Word]
    • NPS questions to ask when evaluating a new medicine [PDF]

     

High Use IPU Medicines

In general, hospitals have been recommended to consider adding to formulary those medicines which have had more than three IPU applications approved. However many of these medicines are expensive and use requires ongoing monitoring to ensure there are no cost blowouts. Some hospitals have developed streamlined IPU forms to facilitate DTC approval processes for these medicines but ensure that outcomes are monitored and DTC continues to have oversight of the medicines use. 

Below are examples of streamlined IPU forms from St Vincent’s Hospital:

  • Azithromycin for Lung Transplant Patients [PDF]
  • Baxter Bottles [PDF]
  • Everolimus [PDF]
  • Levosimendan [PDF]
  • Pulmonary Arterial Hypertension [PDF]
  • Rituximab in Lung Transplant patients [PDF]

 

Other Resources for DTC decision makers

CEC:

CATAG:

The National Prescribing Centre in the UK released a report and competancy framework on “Defining Guiding Principles for Processes supporting Local Decision Making about Medicines” in January 2009.

In addition the NPC has released an e–Learning package that considers the legal and ethical aspects of local decision-making about the funding of medicines and treatments.

 

Page last updated 17 August 2021